Purpose
The Office of Research on Women's Health (ORWH) and the National Institute of General Medical Sciences (NIGMS), along with Institutes and Centers (ICs) of NIH participating in this Notice, announce the availability of administrative supplements to IDeA awards to expand research and research capacity in the IDeA states to address important issues of women’s health across the lifespan. The proposed research must address at least one of the strategic goals of the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research "Advancing Science for the Health of Women." Research on maternal and infant morbidity and mortality is of particular interest.
Background
ORWH is the first Public Health Service office dedicated specifically to promote women's health research within and beyond the NIH scientific community. ORWH was established in September 1990 by Congressional mandate. Congress assigned a far-reaching leadership role for ORWH by mandating that ORWH serves as the focal point for coordinating women’s health research at NIH. ORWH crafts and implements the NIH Strategic Plan for Women's Health Research in partnership with NIH ICs and co-funds research on the role of sex and gender on health with the ultimate goal of advancing rigorous research relevant to the health of women. ORWH also collaborates with NIH ICs, the NIH Office of Extramural Research, and the NIH Office of Intramural Research to monitor adherence to NIH's Inclusion Policies for Research Involving Human Subjects, which ensure that women and minorities are represented in NIH-supported clinical research.
ORWH's interdisciplinary research and career development initiatives stimulate research on sex and gender differences and provide career support to launch promising women's health researchers. These programs set the stage for improved health for women and their families and career opportunities and advancement for a diverse biomedical workforce.
The Institutional Development Award (IDeA) program is congressionally mandated and administered by NIGMS. It supports research and research capacity building in states that historically have had low levels of NIH funding through a variety of funding mechanisms. The IDeA program has been instrumental in increasing the pool of Early Stage Investigators (ESIs) from IDeA states who apply for NIH research project grants and in strengthening research infrastructure in those states.
Residents in IDeA states, especially those living in rural areas, often have less access to health care and suffer from poorer health outcomes, including health outcomes for women and children, than the average American. For example, several IDeA states are among the states with the highest maternal and infant mortality rates. These administrative supplements aim to increase research specifically directed at women’s health and health disparities and to expand the capacity of IDeA states to conduct women’s health research.
Research Objectives
This NOSI encourages a broad range of research addressing important issues of women’s health with a special interest in maternal and infant morbidity and mortality, including their underlying causes.
Eligibility
Eligibility for this supplement program is limited to current awardees of the following NIGMS programs:
The Centers of Biomedical Research Excellence (COBRE) program, which supports the establishment and development of innovative, state-of-the-art biomedical and behavioral research centers at institutions in IDeA-eligible states through awards for three sequential five-year phases.
The IDeA Networks of Biomedical Research Excellence (INBRE) program, which supports a statewide biomedical research development network in each IDeA-eligible state that partners research-intensive institutions with primarily undergraduate institutions, community colleges and tribally controlled colleges and universities, providing access to biomedical research experiences for promising undergraduate students.
The IDeA Program Infrastructure for Clinical and Translational Research (IDeA-CTR), which enhances the ability of IDeA state institutions and investigators to develop competitive clinical and translational research programs and address health conditions that affect the medically underserved and/or are prevalent among populations in IDeA states.
Only one supplement request per COBRE, INBRE, or IDeA-CTR grant will be accepted. Each request may include only one research project, which must be within the scope of the parent grant and appropriate for the duration of one year.
Institute-, Center-, and Office-Specific Research Interests
NCCIH
The mission of the National Center for Complementary and Integrative Health (NCCIH) is to determine, through rigorous scientific investigation, the fundamental mechanisms, usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care. For purposes of this FOA, NCCIH is interested in research investigating complementary and integrative health approaches to improve maternal health outcomes. Natural products include botanicals, probiotics/microbials, naturally-derived peptides, dietary supplements, and special diets. Mind-body approaches include various meditation approaches (e.g., mindfulness), hypnosis or guided imagery, meditative movement approaches (e.g., yoga, tai chi, qi-gong), body-based approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), a combination of these approaches (e.g., meditation and yoga, such as in mindfulness-based stress reduction MBSR), or complex interventions including music and art therapy.
Areas of programmatic interest to NCCIH include, but are not limited to, the following:
- Studies to evaluate the utilization of complementary health approaches for managing symptoms such as perinatal and postpartum depression, stress, anxiety, pain, and sleep disturbance and assess their impact on maternal health outcomes
- Research on the use of complementary health approaches to support pregnant and parenting women with opioid use disorder
- Studies examining the contributions of sex, gender, and the intersection of sex and gender on the mechanisms of action of complex interventions including various mind and body approaches and natural products
- Research designed to investigate the influence of sex and gender on utilization of complementary health approaches to improve health outcomes among diverse populations, including gender diverse populations
NCCIH will accept projects proposing secondary analyses, observational studies, basic, and mechanistic studies (animal and human). NCCIH will not accept assignment of applications that propose new clinical trials. NCCIH will not accept single-site or multi-site efficacy or effectiveness research through this FOA (please see NCCIH Clinical Trial Funding Opportunities instead). Investigators are strongly encouraged to discuss their plans with NCCIH Scientific/Research contact prior to submitting their application to identify the most appropriate FOA for their research.
NEI
The National Eye Institute (NEI) is interested in supporting research in its programmatic areas (https://www.nei.nih.gov/grants-and-training) that addresses important issues of women’s health especially those focused on maternal and infant morbidity.
NHLBI
The National Heart, Lung, and Blood Institute (NHLBI) supports basic, preclinical, translational, and clinical research that leads to improvement of heart, lung, blood, and sleep (HLBS) health outcomes for women.
Research areas of particular interest to NHLBI for this NOSI include approaches that are relevant across more than one HLBS area including but not limited to:
- Impact of sex and hormones in lung conditions, (i.e., conditions with clinical presentation or higher prevalence in women, impact of hormonal changes throughout the lifecourse, including physical changes during pregnancy which can worsen pre-existing lung conditions and introduce new symptoms).
- Examine basic and clinical mechanisms linking sleep deficiency and sleep disorders pre-pregnancy and during gestation to adverse maternal cardiovascular and metabolic outcomes.
- Thrombo-embolic events related to high endogenous or exogenous sex hormones such as contraceptive treatment or pregnancy or post-delivery; explore the role of different cell subsets or tissues (platelets, endothelial cells, leukocytes, liver); differentiate genomic from epigenetic from co-morbidities mechanisms.
- Understand the role of sex hormones in the distribution imbalance seen for some blood diseases such as essential thrombocythemia that affects women twice more frequently than men. The role of estrogens/estrogen receptors on hematopoietic stem cells and their niche as well as their expression on the subsequent megakaryocytic/platelet lineage is one research area to explore. Other examples of disease distribution imbalance between women and men could be uncovered by following this area of research.
- Identification of mechanisms underlying HLBS diseases and their risk, including obesity, throughout a woman’s lifecourse and in women from different races/ethnicities/origins/heritage groups.
- Identification of mechanisms underlying women’s resilience for certain HLBS diseases.
- Detection and prediction of HLBS disorders during pregnancy and/or the postpartum period.
- Development of approaches or interventions that target pregnancy-related HLBS disorders and/or underlying risk factors, including obesity, and assess their impact on maternal health status.
- Identification of determinants of health disparities throughout a woman’s lifecourse (including pregnancy and postpartum) as well as factors that contribute to optimal women’s and/or maternal health in high risk communities.
- Identification of barriers to delivery of effective maternal health therapies and development and testing of implementation strategies to effectively address those barriers.
NHGRI
The National Human Genome Research Institute (NHGRI) supports the development of resources, approaches, and technologies that accelerate and support studies focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; genomic data science and bioinformatics; training, developing, and expanding the diversity of the genomics workforce; and ethical, legal, and social issues related to genomic advances. More details about the institute’s vision and priority areas can be found in the 2020 NHGRI Strategic Vision.
NIA
The National Institute on Aging (NIA) will accept applications for research projects in areas within the Institute's mission, including genetic, biological, behavioral, social, and economic research on aging. In addition, NIA encourages applications on Alzheimer’s disease (AD) and AD-related dementias (ADRD). The NIA website provides further information about the Institute’s mission and areas of research interest. A specific priority is understanding the environmental, sociocultural, behavioral and biological drivers of health inequities and disparities related to aging among older women, as outlined in NIA’s strategic directions for health disparities research and reflected within NIA’s Health Disparities framework. For additional scientific program information and for pre-application guidance, potential applicants are encouraged to contact the NIA Program Director whose portfolio covers the scientific topic of interest.
Specific areas of interest include:
- Research on mechanisms underlying faster rates of aging (the appearance of premature aging in pre- and post-menopausal women).
- The molecular and cellular mechanisms of aging leading to increased risk of disease in post-reproductive women.
- Research to elucidate the influence of complications during pregnancy, such as pre-eclampsia, gestational hypertension and gestational diabetes on brain aging, Alzheimer’s disease and Alzheimer’s disease related dementias.
NIAID
The National Institute of Allergy and infectious Diseases (NIAID) supports basic and translational research to better understand, diagnose, prevent, and treat infectious and immune-mediated diseases, including diseases that impact maternal and infant mortality and morbidity. Areas of programmatic interest to NIAID include, but are not limited to, the following:
- Research on all areas of HIV infection, including developing and testing preventive HIV vaccines, and other non-vaccine biomedical prevention strategies such as long-acting pre-exposure prophylaxis (PrEP), and new strategies for controlling or eliminating HIV infection and AIDS-associated opportunistic infections.
- Basic and applied research to better understand, treat, and ultimately prevent other infectious, immunologic, and allergic diseases.
NIBIB
Interests of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest (https://www.nibib.nih.gov/research-funding) to determine if their research fits within the NIBIB mission.
If work is proposed involving clinical trials, NIBIB will only consider funding support for in-scope early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development or mechanistic trials where the primary focus of the project is on technology development.
NICHD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supports a broad range of research addressing important issues in women’s health, including maternal and infant mortality and morbidity. Areas of particular interest to NICHD include, but are not limited to:
- How race/ethnicity (especially among American Indian/Alaska Native populations), age and other demographic characteristics, socioeconomic status, and nutrition relate to maternal mortality and its causes; the incidence, diagnosis, and treatment of gynecologic disorders; and other women's health concerns.
- The development of novel and effective pharmacotherapeutic strategies to improve clinical outcomes for mothers and infants.
- The discovery or validation of biomarkers that predict adverse pregnancy outcomes or predict medication levels in breastmilk.
- Studies of maternal, neonatal and infant outcomes of pregnancy in infertile couples, stratified by male/female factors and infertility cause, especially endometriosis.
- Studies of fertility status as a biomarker for women’s overall health.
NIDA
The National Institute on Drug Abuse (NIDA) supports and conducts biomedical research to understand, prevent and treat drug use and its consequences. For this announcement, NIDA is interested in basic and clinical research projects in females or sex/gender differences in drug use and addiction, its etiology and prevention, its consequences and the underlying neurobiological, social and behavioral mechanisms.
NIEHS
The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people to promote healthier lives. For this announcement, NIEHS is interested in supporting research that addresses or seeks to understand how exposures to toxic chemical and non-chemical environmental insults alter biologic processes that may be linked to disease in women, particularly maternal and infant mortality and morbidity. Equally important is research examining women’s health at the intersection of chemical, physical, built, and social environments. Examples of environmental exposures relevant to the mission of the NIEHS include, but are not limited to, industrial chemicals, e-waste, emerging and legacy endocrine-disrupting chemicals, indoor air pollutants from cooking and other sources, climate variability and the environmental impacts of natural and man-made disasters.
NINR
The National Institute of Nursing Research (NINR) supports research that builds the scientific foundation for nursing practice and policy across clinical and community settings, and advances the prevention, detection, and management of disease and disability. NINR-funded research draws on nursing’s holistic perspective, to carry out basic, clinical, population, and translational studies that integrate factors at multiple levels – from molecules at the biological level up to social determinants and macro level factors – to identify their role in health, health improvement and health inequities. For this announcement, NINR is interested in projects aimed at improving the health of women as individuals, or in populations, translating science in order to maximize the impact of findings on practice and policy, and will give priority to projects examining health disparities in maternal health.
ODP
The mission of the Office of Disease Prevention (ODP) is to improve public health by increasing the scope, quality, dissemination, and impact of prevention research supported by the NIH. The ODP is interested in supporting research to test interventions that address risk factors associated with maternal and infant morbidity and mortality and address maternal and infant health disparities. In addition, the ODP encourages applications to support projects led by early stage investigators. For more information about ODP strategic priorities, visit:https://prevention.nih.gov/about-odp/strategic-plan-2019-2023.
Information on Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions is available at https://researchmethodsresources.nih.gov/.
ORWH
The Office of Research on Women’s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH, and throughout the scientific community. ORWH is interested in research that addresses maternal health risks and morbidities, with emphasis on examining connections between pathogenic factors and disease development in the context of the life course, for example pregnancy complications linked to subsequent risks to the health of women, e.g.:
- Gestational Diabetes and development of Type 2 Diabetes
- Preeclampsia and subsequent risks of cardiovascular disease, including stroke and deep venous thrombosis.
- Peripartum depression and subsequent risks of major depression, substance use and suicide in women. The perinatal period is an opportunity to screen, identify and treat other mental disorders even if preexisting.
ORWH encourages interdisciplinary approaches and partnerships to support research that examines ways to integrate evidence-based practices, interventions, and application of evidence and implementation of policies into practice settings to improve the health of women across the life course.
For more information on ORWH and The Trans-NIH Strategic Plan for the Health of Women covering FY 2019 – 2023, please visit ORWH website (https://www.nih.gov/women/strategicplan) for additional guidance.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
- PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:
- Application Due Date: April 19, 2021 by 5:00 PM local time of applicant organization.
- For funding consideration, applicants must include “NOT-GM-21-018” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
- Only electronic submissions will be accepted for this funding opportunity. Use one of the methods described in PA-20-272. Paper submissions and applications submitted as email attachments will be rejected without review.
- Requests can be for no more than $200,000 in direct costs exclusive of Facilities and Administrative costs on sub-contracts. As part of the budget justification, a statement regarding the expenditure of currently available unobligated grant funds should be included. Supplements may provide support above the established dollar limit for the parent grant award.
- Requests may be for one year of support only
- Only one supplement request per COBRE, INBRE, or IDeA-CTR grant will be accepted. Each request may include only one research project, which must be within the scope of the parent grant and appropriate for the duration of one year.
- The parent award must be active when the application is submitted (e.g. within the originally reviewed and approved project period), regardless of the time remaining on the current project.
- Research aims of applications from parent awards that received supplemental funding under NOT-GM-20-017 must be distinct from those funded in FY2020.
- The Research Strategy section of the application is limited to 6 pages and must clearly describe the significance of the project.
- As part of the application, investigators must submit an abstract of the proposed research that shows the research is within the scope of the parent award and is relevant to important issues of women’s health as described in this NOSI.
- Only existing awardees of NIGMS programs described in the Eligibility section of this Notice are eligible to apply.
- Research project(s) proposed in the supplement application must be led by COBRE Research Project Leaders, COBRE or IDeA-CTR Pilot Project Leaders, or the INBRE Developmental Research Project Program investigators presently or previously supported by the current five-year parent award.
- Co-Project Leads are allowed for collaborative projects.
- The PD/PIs of the parent awards cannot serve as Project Leads for the proposed research, nor use the supplemental funds to support their own research.